Study Status

Nickname OAK-38
Status Active
Site Activation 146 / 150 (97.3%)
Participant Enrollment 779 / 1000 (77.9%)

Study Overview

8 Red KRIs
72 Amber KRIs

Summary Charts

Group Overview

As of 2025-04-01, AA-AA-000-0000 has 779 participants enrolled across 146 sites. 80 Site-KRI combinations have been flagged across 56 sites as shown in the Study Overview Table above.
  • 8 sites have at least one red KRI
  • 56 sites have at least one red or amber KRI
  • 92 sites have neither red nor amber KRIs

Results

Adverse Event Rate

Summary Charts

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Time Series
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X1750 (Smith) 8 41 282 0.15 2.95
0X3943 (Smith) 5 11 49 0.22 2.82
0X3596 (Smith) 6 4 146 0.03 -1.96
0X5895 (Deer) 5 19 373 0.05 -1.84
0X3154 (Doe) 5 3 111 0.03 -1.72
0X7632 (Smith) 2 1 65 0.02 -1.59
0X8788 (Deer) 10 28 471 0.06 -1.53
0X847 (Smith) 4 6 142 0.04 -1.43
0X9460 (Doe) 5 2 74 0.03 -1.41
0X2944 (Deer) 3 5 123 0.04 -1.38
0X9142 (Smith) 13 50 747 0.07 -1.35
0X5329 (Smith) 12 25 406 0.06 -1.30
0X5550 (Deer) 4 2 65 0.03 -1.23
0X1892 (Deer) 3 2 61 0.03 -1.15
0X4135 (Smith) 2 1 43 0.02 -1.14
0X1910 (Deer) 6 13 220 0.06 -1.06
0X8638 (Doe) 8 14 232 0.06 -1.04
0X3090 (Smith) 7 17 273 0.06 -1.03
0X2903 (Deer) 2 1 38 0.03 -1.02
0X1912 (Doe) 4 6 117 0.05 -1.02
0X1146 (Smith) 8 18 285 0.06 -1.01
0X6900 (Deer) 3 10 174 0.06 -1.01


Serious Adverse Event Rate

Summary Charts

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Time Series
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X3943 (Smith) 5 7 49 0.14 3.42
0X4353 (Doe) 2 5 39 0.13 2.61
0X4485 (Doe) 7 23 327 0.07 2.49
0X9580 (Deer) 9 23 341 0.07 2.28
0X1750 (Smith) 8 19 282 0.07 2.07
0X6227 (Smith) 6 6 63 0.10 2.05
0X759 (Smith) 6 21 321 0.07 2.04
0X9460 (Doe) 5 0 74 0.00 -1.75
0X1910 (Deer) 6 4 220 0.02 -1.71
0X5895 (Deer) 5 9 373 0.02 -1.67
0X9142 (Smith) 13 23 747 0.03 -1.48
0X4135 (Smith) 2 0 43 0.00 -1.33
0X1257 (Doe) 5 5 212 0.02 -1.30
0X6457 (Smith) 3 3 144 0.02 -1.23
0X3154 (Doe) 5 2 111 0.02 -1.22
0X5384 (Smith) 8 11 379 0.03 -1.22
0X8593 (Doe) 2 0 36 0.00 -1.22
0X350 (Deer) 9 4 174 0.02 -1.21
0X6900 (Deer) 3 4 174 0.02 -1.21
0X1146 (Smith) 8 8 285 0.03 -1.14
0X3909 (Smith) 10 12 395 0.03 -1.12
0X8788 (Deer) 10 15 471 0.03 -1.07
0X8625 (Deer) 6 12 389 0.03 -1.06
0X9737 (Doe) 5 10 333 0.03 -1.06
0X5550 (Deer) 4 1 65 0.02 -1.04
0X7632 (Smith) 2 1 65 0.02 -1.04


Non-Important Protocol Deviation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X4197 (Smith) 5 7 69 0.10 2.14
0X1912 (Doe) 4 10 117 0.09 2.04


Important Protocol Deviation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X421 (Doe) 8 14 156 0.09 2.51
0X1750 (Smith) 8 21 282 0.07 2.27
0X8638 (Doe) 8 2 232 0.01 -2.25
0X6457 (Smith) 3 0 144 0.00 -2.21
0X2532 (Doe) 10 24 350 0.07 2.06
0X213 (Smith) 12 43 706 0.06 2.05
0X8764 (Smith) 4 12 147 0.08 2.01


Grade 3+ Lab Abnormality Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X6985 (Doe) 8 124 6482 0.02 2.82
0X8786 (Deer) 7 155 8553 0.02 2.50
0X1887 (Smith) 3 45 2160 0.02 2.26


Study Discontinuation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X8091 (Smith) 6 4 6 0.67 5.00
0X8625 (Deer) 6 3 6 0.50 3.56
0X4959 (Doe) 10 3 10 0.30 2.37


Treatment Discontinuation Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X6405 (Doe) 10 5 10 0.50 3.53
0X5895 (Deer) 5 3 5 0.60 3.15
0X213 (Smith) 12 5 12 0.42 3.02


Query Rate

Summary Charts

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Metric Table

Nothing flagged for this KRI.


Delayed Query Resolution Rate

Summary Charts

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Time Series
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X2192 (Deer) 13 3912 4230 0.92 2.32
0X8786 (Deer) 7 1573 1692 0.93 2.24
0X9824 (Deer) 5 355 376 0.94 2.15
0X101 (Deer) 3 616 658 0.94 2.05


Delayed Data Entry Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X2903 (Deer) 2 35 376 0.09 3.74
0X9360 (Smith) 8 541 9776 0.06 2.41
0X7632 (Smith) 2 51 752 0.07 2.20
0X5309 (Smith) 3 50 752 0.07 2.03


Data Change Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X1712 (Smith) 3 445 1504 0.30 3.00
0X3738 (Smith) 2 853 3008 0.28 2.77
0X4323 (Smith) 10 12377 46624 0.27 2.37
0X2323 (Smith) 12 9185 34592 0.27 2.07


Screen Failure Rate

Summary Charts

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Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X1783 (Doe) 3 5 8 0.62 2.79
0X5895 (Deer) 5 5 10 0.50 2.15


PK Collection Compliance Rate

Summary Charts

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Metric Table

Nothing flagged for this KRI.


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold AccrualThreshold AccrualMetric Priority Flag MetricID
Analysis kri0001 Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator 0 NA Analysis_kri0001
Analysis kri0002 Site SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 Denominator 0 NA Analysis_kri0002
Analysis kri0003 Site PD Non-Important Protocol Deviation Rate Non-Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 Denominator 0 NA Analysis_kri0003
Analysis kri0004 Site IPD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 Denominator 0 NA Analysis_kri0004
Analysis kri0005 Site LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation binary Adjusted Z-Score 2,3 10 Numerator 0 0,1,2 Analysis_kri0005
Analysis kri0006 Site SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator 0 0,1,2 Analysis_kri0006
Analysis kri0007 Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score 2,3 3 Numerator 0 0,1,2 Analysis_kri0007
Analysis kri0008 Site QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 Analysis_kri0008
Analysis kri0009 Site OQRY Delayed Query Resolution Rate Queries That Were Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 Analysis_kri0009
Analysis kri0010 Site ODAT Delayed Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score 2,3 30 Numerator 0 0,1,2 Analysis_kri0010
Analysis kri0011 Site CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score 2,3 100 Numerator 0 0,1,2 Analysis_kri0011
Analysis kri0012 Site SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 Denominator 0 NA Analysis_kri0012
Analysis kri0013 Site PK PK Collection Compliance Rate PK Samples Collected PK Samples Expected Identity identity PK Collection Compliance Rate 0.9,0.85 3 Difference 0 -2,-1,0 Analysis_kri0013